ICH Guideline E6(R1): GCP with 100% correct answers

What is GCP? Good clinical practice is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. What is the purpose of GCP? To provide a unified standard for the EU, Japan, and the US to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. Brainpower Read More 0:04 / 0:15 When is GCP used? When generating clinical trial data that are intended to be submitted to regulatory authorities. What was considered when developing GCP? The EU, Japan, US, Australia, Canada, and Nordic countries GCP along with the World Health Organization. Applicable Regulatory Requirements Any laws or regulations addressing the conduct of clinical trials. Audit A systematic and independent examination of trial-related activities in regards to the accuracy of the conduct and reported data according to GCP, SOPs and other regulatory committees. Audit Certificate A declaration of confirmation by the auditor that an audit has taken place.